Status:
RECRUITING
Feasibility Study of an Angiographic Quantitative Flow Ratio-guided Endovascular Procedure in Patients With Lower Limbs Peripheral Arterial Disease.
Lead Sponsor:
Fondation Hôpital Saint-Joseph
Collaborating Sponsors:
Medis Medical Imaging Systems B.V.
Conditions:
Lower Limbs Peripheral Arterial Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The main objective of this study is to explore the feasibility of using the angiographic Quantitative Flow Ratio (QFR) as a tool to predict the success rate of endovascular revascularization in patien...
Detailed Description
Approximately 202 million people are affected with lower extremity artery disease (LEAD) worldwide, of whom almost 40 million are living in Europe. LEAD usually appears after the age of 50 years, with...
Eligibility Criteria
Inclusion
- Patient with symptomatic Rutherford stage 2 to 6 AOMI with an indication for endovascular revascularization
- Patient with a simple lesion (TASC A) and short stenosis of the superficial femoral artery
- Patient affiliated to a health insurance system
- French-speaking patient
- Patient with free, informed and express oral consent
Exclusion
- Renal failure patients with GFR \< 30 ml/min
- Patient deprived of liberty
- Patients under court protection
- Pregnant or breast-feeding patients
Key Trial Info
Start Date :
April 29 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 24 2025
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT06516315
Start Date
April 29 2024
End Date
May 24 2025
Last Update
July 23 2024
Active Locations (1)
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1
Hôpital Paris Saint-Joseph - 185 Rue Raymond Losserand
Paris, Île-de-France Region, France, 750014